Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

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This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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25 healthy volunteers

No study treatments administered

Intervention Type OTHER

Interventions

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No study treatments administered

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signature of an informed consent;
* Male or female between 18 and 60 years of age.

Exclusion Criteria

* Positive serology for hepatitis B or C or HIV;
* Acute infection at inclusion;
* Severe psychiatric disorder, neurological, inflammatory, or autoimmune disease;
* Pregnancy or breastfeeding;
* Heavy smokers i.e. more than 10 cigarettes per day;
* History of alcohol or drug abuse in the last 3 years;
* Participation in a clinical trial (within the last 3 months).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes